Why?
Clinical studies often fail to recruit and retain diverse participants that accurately represent the general population. This leads to knowledge gaps in the research of many diseases and conditions, preventative factors and effectiveness of treatments in different demographic groups. It is imperative for clinical research to actively engage with demographic and ethnic minority communities, as well as other marginalized groups facing disparities in healthcare, including sexual, gender, and age diversity, and socioeconomically disadvantaged groups. However, these underserved (US) and underrepresented (UR) communities often face barriers like geographic limitations, mistrust, poor communication, and prejudice when participating in clinical trials.
REaDI strives to tackle these challenges by fostering a more cohesive and integrated ecosystem around clinical studies. This involves better and more actively connecting all the key stakeholders who can facilitate access to a wide array of patient populations.
What?
REaDI will provide participating stakeholders with the necessary tools, training programs, and approaches essential for the recruitment and retention of patients in inclusive clinical studies, as well as develop and implement a patient-centred, sustainable, open and innovative digital platform to foster all these new and existing tools and to connect the created communities. The project will also implement at least 3 pilot use cases to test the effectiveness of the developed tools and approaches. REaDI is designed to transform clinical trial ecosystems and capabilities, with patients at the center, and key stakeholders working together from the design through to the delivery phase.
With whom?
The REaDI consortium is an interdisciplinary, multi-stakeholder combination of 73 organizations from 18 countries, with key expertise in clinical trials, engagement strategies for US and UR populations, digital platform development, training and capability building initiatives, effective communication and dissemination, long-term sustainability, ethics and regulatory affairs, which will enforce the project’s success.
How?
EATG will lead Task 4.5, which focuses on raising awareness and building trust, by developing and implementing a training program tailored for the general public, and Task 6.1, which centres on developing and reinforcing the different connections and partnerships by mapping community stakeholder connectivity, needs, and expectations.
For what outcome?
- Increasing awareness and knowledge about US/UR communities across Europe (WP1)
- Reducing the burden of clinical studies through new tools, approaches, and solutions (WP2-6)
- Improving the representativeness of US/UR populations in clinical studies
Community Advisory Group
Maka Gogia
Laura Pinnavaia
Daniela Rojas Castro
Nuala Ryan
Vasiliki-Rafaela Vakouftsi
Brian West
| EATG contact person(s) : | Shatyam Issur (READI Project Coordinator) – shatyam.issur@eatg.org |
| Duration of the project/initiative : | January 2024 – December 2030 |
| Project/Initiative Leader : | SERVICIO MADRILENO DE SALUD The Synergist |
| Project/initiative Main Partner(s) : | The consortium is led by the Servicio Madrileño de Salud and composed of 73 partners from 18 countries:
|
| Budget : | 561,575 € |
| Main Funding Sources : | Innovative Health Initiative (IHI) COCIR MedTech Europe European Federation of Pharmaceutical Industries and Associations (EFPIA) Vaccines Europe EuropaBio European Union |
| Links: | https://ihi-readi.org/ |
| Communication Disclaimer : | This project is supported by the Innovative Health Initiative Joint Undertaking (IHI JU) under grant agreement No 101166227. The JU receives support from the European Union’s Horizon Europe research and innovation programme and COCIR, EFPIA, EuropaBio, MedTech Europe, Vaccines Europe, and Medicines and Healthcare Products Regulatory Agency and Breakthrough T1D. This project is also supported by UKRI (UK Research and Innovation) under grant agreement No 10152425 for National Institute for Health and Care Excellence and grant agreement No 31052024 for The University Court of the University of Aberdeen. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the aforementioned parties. Neither of the aforementioned parties can be held responsible for them. |
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